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The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

FDA Vaccine Committee Meets About COVID-19 Vaccines

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors

Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic. 

Lachman Now Offers Remote Inspections

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians. 

J&J Pauses COVID-19 Vaccine Candidate Clinical Trials Due to Unexplained Illness 

The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.

LabVantage Awarded US Army Contract for LIMS COVID-19 Vaccine Support

The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.

HHS, DoD, AstraZeneca Enter into $486-Million Agreement for COVID-19 Investigational Product

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

Rentschler to Partner with BioNTech for COVID-19 Vaccine Manufacturing 

Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.

Independent Research Demonstrates Effectiveness of Alfacyte Against SARS-CoV-2

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

First Participant Dosed in CureVac’s COVID-19 Vaccine Clinical Trial

Experts fear confusion over allocation process, cold-chain requirements, IT systems. 

COVID-19 Vaccine Distribution Raises Multiple Challenges

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

EMA Confirms Standards for COVID-19 Treatment Evaluations

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Regulatory Review of COVID-19 Vaccine Begins in Europe

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Reconfiguring Fill/Finish Inspection to Meet COVID-19 Vaccine Goals

Misleading messages contribute to eroding trust in public health agencies

The (Dis)Information Pandemic

The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.  

Serum Institute of India, Gavi, and Bill & Melinda Gates Foundation Pledge Another 100 Million COVID-19 Vaccine Doses to India and LMICs

The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.

CRB Completes Facility Construction for GRAM COVID-19 Vaccine Manufacturing

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.

Novavax and Par Sterile Products Enter into Fill/Finish Manufacturing and Services Agreement for COVID-19 Vaccine Candidate

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility. 

GRAM Partners with Johnson & Johnson for Fill/Finish of Vaccine Candidate

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19. 

COVID-19 Update